Celltrion Begins Global Clinical Trials for Two Follow-up Biosimilars

[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 12th that it has officially begun global clinical trials for two follow-up biosimilars, including treatments for asthma and autoimmune diseases.

'CT-P39', a biosimilar of the allergic asthma and chronic urticaria treatment 'Xolair' (generic name omalizumab), has entered Phase 3 clinical trials and plans to complete them by 2022. Xolair is an antibody biopharmaceutical developed by Genentech and Novartis, and according to last year's financial results disclosed by Novartis and Roche, who hold the rights, it recorded sales of 3.9 trillion KRW.

'CT-P43', a biosimilar of the autoimmune disease treatment 'Stelara' (generic name ustekinumab), has also started Phase 1 clinical trials. The goal is to complete Phase 1 by the first half of next year and enter Phase 3 clinical trials in the second half of this year. Stelara is an autoimmune disease treatment developed by Janssen for psoriasis, Crohn's disease, and ulcerative colitis.

Celltrion expects these two follow-up biosimilars, along with 'CT-P17' (a Humira biosimilar) which was submitted for approval to the European Medicines Agency (EMA) in March, and 'CT-P16' (an Avastin biosimilar) currently undergoing global Phase 3 clinical trials, to become the company's core product lineup.

A Celltrion official stated, "We will strive to successfully conduct clinical trials for CT-P39 and CT-P43 and introduce the products early to global markets such as the United States and Europe."

This content was produced with the assistance of AI translation services.